Direct Report from Sweden on New Potential Treatments

Oct 16 2010

A Swedish study confirmed that the risk of getting MS goes up if you have been exposed to the Epstein-Barr virus (which causes mononucleosis, “mono”) .  Smoking  and low vitamin D blood levels further increase your risk of developing MS.  People born with certain genetic types are particularly at risk if exposed to Epstein-Barr virus or smoke.  Although you can’t change your genes, you can reduce the risk of developing MS if you stop smoking for greater than five years.

The TEMSO trial randomly assigned 365 patients to 7 mg oral teriflunomide daily, 358 patients to 14 mg oral terflunomide daily, and 366 patients to placebo (no treatment).  The MS patients had less relapses on treatment than on placebo (31.5% less relapses on the 14 mg dose and 31.2% on the 7 mg dose).  Patients on terflunomide 14 mg were 30% less likely to progress in disability than on placebo.  The low dose reduced the risk of worsening disability by 23.7%, but was not statistically significant.  The number of active lesions with contrast (on T1 scan) was 80% lower on the higher dose and 57% lower on the lower dose.  Side effects and risks seen included diarrhea, nausea, hair thinning, and liver blood test abnomalities.  Of 11 pregnancies, 10 patients had either miscarriages or elective abortions and 1 healthy baby born.  Another Phase III trial studying the experimental medication teriflunomide is still enrolling patients.   To read more on this other teriflunomide trial.

Treatments in earlier stages of development (Phase II trials) had mixed results.  The high dose of oral frategrast, which works like Tysabri, was effective in reducing MRI activity on the high dose (900 or 1200 mg twice a day).  However,  the 27% reduction of relapses on frategrast compared to placebo was not statistically significant.  The antibody therapy ocrelizumab, which focuses on the immune B cells, reduced relapses 80% on 600 mg dose and 73% on 2000 mg dose.   The therapy was also very powerful in reducing new MRI activity.  The biggest concern with the therapy was that one of the 55 patients assigned to the 2000 mg dose died in the 12th week of the trial due to a severe inflammatory reaction with widespread clotting in the blood.  A similar antibody, ofatumumab, reduced MRI activity with contrast greater than 99%.  Out of the 26 ofatumumab-treated patients, 2 people had infusion reaction including hives and cough.

Controversy regarding CCSVI continues!  Dr. Claudio Baracchini of Padua, Italy studied patients with the first attack of MS (with lesions on their MRI consistent with MS).  In a study of 50 MS patients and 50 healthy matched control subjects, only 16% of MS patients had blocked veins on ultrasound per Dr. Zamboni’s CCSVI criteria.  Of  the 8 MS patients that had CCSVI by ultrasound, seven patients were injected with dye (venography) and none had blockages.  Dr. Baracchini, who has been doing neck vessel ultrasounds for 20 years, stated that there was no evidence of vein blockages causing MS.  Fireworks followed when another doctor, unknown to me, stated that greater than 90% of his patients have vein blockages on venography.  My understanding is that the results from CCSVI screening depend on the quality of the ultrasound machine, how the study is performed, and who interprets the results.  For example, veins collapse when compressed too hard with the ultrasound probe or the person is placed certain positions.

With over 5000 researchers and doctors in Gothenburg, Sweden sharing their contributions,  the ECTRIMS meeting was a very important place to learn about and critically review the latest advances in MS.

BY: Barry Singer, MD DATE: October 16, 2010 TOPIC: MS Research News